Arm 1 (Monthly) for Age-Related Macular Degeneration (CAN-TREAT Trial)

N/A

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 12

Awards & highlights

No Placebo-Only Group

Summary

This is an observational study to will evaluate and compare two Ranibizumab treatment regimens (Standard of care) in patients with neovascular (wet) age-related macular degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The results will be used to generate further recommendations on the timing of treatment administration for patients with neovascular (wet) age-related macular degeneration (wAMD). In this context, the study will use the anatomical imaging (for example, optical coherence tomography \[OCT\]) to evaluate wAMD disease activity impacted by the recurrence of disease instability and for decision making in the treatment decision algorithm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Visual Acuity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (Treat and Extend)Experimental Treatment1 Intervention

Three consecutive months of 0.5 mg Ranibizumab intravitreal injections (Day 1, Month 1, and Month 2). Monthly injections will continue until evidence of disease stability is observed. Specifically, monthly treatment will continue until visual acuity is deemed stable as indicated by a gain in visual acuity of ≤ 3 ETDRS letters from the prior month, no clinical evidence of lesion growth, fluid or blood, and no intraretinal or subretinal fluid on OCT. When this is achieved, the intervals between each subsequent injection will be extended by 2 weeks (intervals of 6 weeks, 8 weeks, 10 weeks, to a maximum of 12 weeks) until clinical or diagnostic evidence of disease instability is observed based on OCT findings and/or BCVA ETDRS.

Group II: Arm 1 (Monthly)Experimental Treatment1 Intervention

0.5 mg intravitreal injections of Ranibizumab monthly for the duration of the study.

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